GIBECKRecalls & reported problems across all models
Teleflex Incorporated · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one GIBECK model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 2
We found 7 models of GIBECK by Teleflex Incorporated in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between May 7, 2021 and Jul 28, 2026 — classified as 6 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (7 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
GIBECK recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 29, 2022Open, Classified
Incidents of device splitting or detaching during use
Z-0074-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Aug 29, 2022Open, Classified
Incidents of device splitting or detaching during use
Z-0072-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported GIBECK problems
Device problems
- Obstruction of Flow7
- Disconnection4
- Material Separation4
- Material Split, Cut or Torn3
- Blocked Connection2
- Defective Device2
- Fitting Problem2
- Loose or Intermittent Connection2
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- Insufficient Information5
- Low Oxygen Saturation5
- Capsular Contracture1
GIBECK models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GIBECK IPN043751Filter, bacterial, breathing-circuit2 recalls7 reports
- GIBECK IPN043768Filter, bacterial, breathing-circuit8 reports
- GIBECK IPN043782Filter, bacterial, breathing-circuit6 reports
- GIBECK IPN041364CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)5 reports
- GIBECK IPN929912CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)4 reports
- GIBECK IPN042838Filter, bacterial, breathing-circuit1 report
- GIBECK IPN043834CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)1 report
Recent GIBECK adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2026Fitting Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50058854 ↗MalfunctionJul 28, 2026Fitting Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50058810 ↗MalfunctionApr 20, 2026Loose or Intermittent Connection
IT WAS REPORTED THAT "THE USER WAS UNABLE TO CONNECT THE OXYGEN PORT OF THE TRACH-VENT TO THE TRACHEOSTOMY TUBE DURING USE, AS THE CONNECTION WAS TOO LOOSE. IT OCCURRED TO (B)(4) UNITS IN A ROW, TO THE SAME PATIENT. THEREFORE, A NEW UNIT OF THE DIFFERENT LOT# (LOT#: UNKNOWN) WAS USED TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT OCCURRED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24931179 ↗MalfunctionApr 20, 2026Loose or Intermittent Connection
IT WAS REPORTED THAT "THE USER WAS UNABLE TO CONNECT THE OXYGEN PORT OF THE TRACH-VENT TO THE TRACHEOSTOMY TUBE DURING USE, AS THE CONNECTION WAS TOO LOOSE. IT OCCURRED TO 2 UNITS IN A ROW, TO THE SAME PATIENT. THEREFORE, A NEW UNIT OF THE DIFFERENT LOT# (LOT#: UNKNOWN) WAS USED TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT OCCURRED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24931141 ↗MalfunctionApr 2, 2025Crack; Leak/Splash; Crack; Leak/Splash
IT WAS REPORTED THAT: "THE PATIENT WAS INTUBATED, AND THE ANESTHESIOLOGIST NOTICED A LEAK. HE FINALLY FOUND THAT THE LEAK WAS COMING FROM THE FILTER. THE FILTER WAS CRACKED. WE REMOVED THE FILTER AND REPLACED WITH A NEW ONE AND NO FURTHER PROBLEMS WERE ENCOUNTERED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21750823 ↗MalfunctionMar 26, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT: "(B)(6) 2025, WHEN THE DOCTOR PREPARED THE RESPIRATORY CIRCUIT, HE FOUND THAT THE DISPOSABLE HEAT AND HUMIDITY EXCHANGER FAILED, MANIFESTED AS A RUPTURE AT THE END-EXPIRATORY CO2 JUNCTION. THE PATIENT WAS DESCRFIBED AS FINE POST THE INCIDENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21696400 ↗InjuryFeb 20, 2025Blocked Connection; Blocked Connection
IT WAS REPORTED THAT "WE HAD A BACTERIAL FILTER FAIL ON ONE OF OUR ANESTHETIC MACHINES CAUSING THE PATIENT TO DESATURATE AND DRUGS WERE GIVEN TO THE PATIENT TO NO EFFECT. ON FURTHER INVESTIGATION IT WAS DISCOVERED THAT PART OF THE PAPER FILTER WAS MOVING WITH THE PATIENT RESPIRATIONS. THE FILTER WAS NOT WET. THERE MAY ALSO HAVE BEEN A LEAK AT THE BOTTOM OF THE CO2 SAMPLING PORT. ONCE THE FILTER WAS REPLACED THE PATIENT'S SATS' RETURNED TO NORMAL LEVELS AND THE OPERATION WAS COMPLETED WITHOUT FURTHER ISSUES". THE PATIENT STATUS IS REPORTED AS "FINE". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION.
Patient problems: Low Oxygen Saturation
MAUDE report 21423458 ↗MalfunctionMar 28, 2024Unable to Obtain Readings; Device Sensing Problem; Unable to Obtain Readings; Device Sensing Problem
IT WAS REPORTED THAT: "HEALTHCARE CLINICIAN USED A HUMID-VENT PEDI FILTER ON A PATIENT IN THE DAY CLINIC AND WAS UNABLE TO OBTAIN A CO2 READING ON THE CAPNOGRAPH. CLINICAL CONSEQUENCES: THE FILTER WAS REPLACED AND THE DR WAS THE ABLE TO OBTAIN THE DESIRED READING. ".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18993202 ↗MalfunctionMar 11, 2024Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT : "THE DEVICE WAS DISCOVERED TO HAVE A PARTIALLY BLOOKED PORT. THERE WAS NO CO2 TRACE WHEN EXPECTED, ISOLATED FAULT TO HME, NOTICED SAMPLING PORT LUMEN WAS BLOCKED." ADDITIONAL INFORMATION: THERE WAS NO HEALTH CONSEQUENCES TO THE PATIENT AND NO DESATURATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18874122 ↗MalfunctionFeb 27, 2024Obstruction of Flow; Blocked Connection; Obstruction of Flow; Blocked Connection
IT WAS REPORTED THAT " ABSENT CAPNOGRAPHY TRACE DESPITE BEING ABLE TO VENTILATE THE PATIENT. ON INSPECTION, NO OPENING BETWEEN THE CAPNOGRAPHY PORT AND THE FILTER ".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18786898 ↗InjuryOct 9, 2023Defective Device; Defective Device
IT WAS REPORTED THAT, "BLOCKAGE IN FILTER PREVENTING VENTILATION OF PEDIATRIC PATIENT. SEEMS TO HAVE PLASTIC INSIDE IT CAUSING BLOCKAGE. PATIENT WAS UNABLE TO BE VENTILATED. NO CARBON DIOXIDE READING WAS OBTAINED. ALL ASPECTS OF CIRCUIT WERE EXAMINED. THE FILTER WAS FOUND TO BE THE CAUSE". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.
Patient problems: Insufficient Information
MAUDE report 17897320 ↗MalfunctionOct 6, 2023Defective Device; Defective Device
THE REPORT STATES THAT "THE FILTER HAS A PORTAL WHICH IS BLOCKED WITH A PIECE OF PLASTIC THUS OCCLUDING IT AND NOT ALLOWING THE PATIENT'S ANESTHESIA CIRCUIT TO WORK. IT WAS NOTICED PRIOR TO USE ON A PATIENT". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17887539 ↗MalfunctionMay 11, 2023Disconnection; Disconnection
IT WAS REPORTED THAT PRIOR TO USE WHILE ASSEMBLING THE TUBING, THE FILTER DOES NOT STAY ATTACHED TO THE TUBING AND DISCONNECTS FROM THE WHISPER SWIVEL VALVE EASILY, EVEN IF THE TUBING IS NOT MOVED. ADDITIONAL INFORMATION RECEIVED STATES THAT THE FILTERS ARE COMPATIBLE WITH THE SWIVEL VALVE. NO PATIENT INVOLVEMENT.
Patient problems: Capsular Contracture
MAUDE report 16913347 ↗MalfunctionMay 11, 2023Disconnection; Disconnection
IT WAS REPORTED THAT PRIOR TO USE WHILE ASSEMBLING THE TUBING, THE FILTER DOES NOT STAY ATTACHED TO THE TUBING AND DISCONNECTS FROM THE WHISPER SWIVEL VALVE EASILY, EVEN IF THE TUBING IS NOT MOVED. ADDITIONAL INFORMATION RECEIVED STATES THAT THE FILTERS ARE COMPATIBLE WITH THE SWIVEL VALVE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16913299 ↗MalfunctionMay 11, 2023Disconnection; Disconnection
IT WAS REPORTED THAT PRIOR TO USE WHILE ASSEMBLING THE TUBING, THE FILTER DOES NOT STAY ATTACHED TO THE TUBING AND DISCONNECTS FROM THE WHISPER SWIVEL VALVE EASILY, EVEN IF THE TUBING IS NOT MOVED. ADDITIONAL INFORMATION RECEIVED STATES THAT THE FILTERS ARE COMPATIBLE WITH THE SWIVEL VALVE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16913179 ↗
Other Teleflex Incorporated products
- ARROW1,494 models · 9,043 reports · 62 recalls
- RUSCH220 models · 436 reports · 130 recalls
- WECK97 models · 3,790 reports · 1 recall
- HUDSON RCI152 models · 1,461 reports · 7 recalls
- LANGSTON4 models · 15 reports · 5 recalls
- PLEUR-EVAC15 models · 146 reports · 1 recall
- LMA AIRWAY MANAGEMENT47 models · 139 reports
- UROLIFT13 models · 137 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page